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Abstract Number: 2284

Safety and Efficacy of Lenabasum in Refractory Skin-Predominant Dermatomyositis Subjects Treated on an Open-Label Extension of Trial JBT101-DM-001

Victoria P. Werth1,2, David Pearson1,2, Joyce Okawa1,2, Rui Feng3, Josef Concha1,2, Basil Patel1,2, Emily Hejazi1,2, Caitlin Cornwall4, Scott Constantine4 and Barbara White4, 1University of Pennsylvania, Philadelphia, PA, 2Philadelphia Veterans Affairs Medical Center, Philadelphia, PA, 3University of Pennsylvania, Philadelphia', PA, 4Corbus Pharmaceuticals, Inc., Norwood, MA

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Amyopathic dermatomyositis, clinical trials, Cutaneous manifestations, dermatomyositis and patient outcomes

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Session Information

Date: Tuesday, October 23, 2018

Session Title: Muscle Biology, Myositis and Myopathies Poster III: Treatment and Classification Criteria

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Lenabasum is a synthetic, non-immunosuppressive, selective cannabinoid receptor type 2 agonist that activates resolution of innate immune responses. Lenabasum had acceptable safety and tolerability and improved efficacy outcomes in the double-blinded, randomized, placebo-controlled (DBPC) part A of Phase 2 trial JBT101-DM-001 (NCT02466243) in dermatomyositis (DM) subjects with refractory, skin-predominant involvement.

Objective: To provide long-term safety and efficacy data in DM subjects in study JBT101-DM-001.

 

Methods: Subjects who completed Part A were eligible to receive oral lenabasum 20 mg BID in an open-label extension (OLE) that assessed safety and efficacy at 4 weeks, then every 8 weeks.

Results: 20/22 (90.9%) eligible subjects received open-label lenabasum, following a mean interval of 31 weeks from end of Part A to start of OLE when they received only standard-of care. 17/20 (85.0%) subjects were on stable baseline immunosuppressive drugs. At the time of data cut-off, no subjects had discontinued from the OLE, all completed Week 22 and 17 (85%) completed ≥ Week 28. Adverse events (AEs, n = 33) occurred in 13/20 (65.0%) subjects, with 5/20 (25.0%) subjects having ≥ 1 AE (all mild) related to lenabasum.  No subject had a serious or severe AEs.  All subjects had AEs with maximum severity of mild (12/20, 60.0%) or moderate (1/20, 5.0%). The only AE that occurred in more than 1 subject was DM flare (n = 2, 10%); the last recorded CDASI activity score prior to flare was 14 points lower than baseline in 1 subject and 5 points higher than baseline in 1 subject. Mild dizziness occurred in 1 (5.0%) subject.

Improvement was seen in multiple physician- and patient-reported efficacy outcomes including: CDASI activity score; physician VAS assessments of skin activity and extra-muscular disease; physician Likert assessments of global disease, skin disease, and extra-muscular disease; and patient VAS assessments of overall disease, skin disease, itch, pain, and several SkinDEX-29 and PROMIS-29 domain scores. Examples in shown in Figure 1. Mean (SD) changes at Week 28 from study start were: CDASI activity score = –15.4 (9.24) points, with 14/17 (82.3%) subjects achieving ≥ 10-point improvement and 8/17 (47.1%) subjects achieving low disease activity with CDASI ≤ 14; 10-cm Physician Overall Disease VAS = -2.6 (1.90) points, with 14/17 (82.3%) subjects achieving ≥ 1 point and 20% improvement.

Conclusion: Lenabasum continues to have a favorable safety and tolerability profile in the OLE of the Phase 2 trial JBT101-DM-001 with no severe or serious AEs or study discontinuations related to lenabasum.  The CDASI activity score and multiple other physician and patient-reported outcomes improved, although limitations of attributing efficacy to lenabasum in the setting of open-label dosing is acknowledged.  These data support further testing of lenabasum for the treatment of DM.


Disclosure: V. P. Werth, Corbus Pharmaceuticals, Inc., 5, 9; D. Pearson, None; J. Okawa, None; R. Feng, None; J. Concha, None; B. Patel, None; E. Hejazi, None; C. Cornwall, Corbus Pharmaceuticals, Inc., 3; S. Constantine, Corbus Pharmaceuticals, Inc., 3; B. White, Corbus Pharmaceuticals, Inc., 3.

To cite this abstract in AMA style:

Werth VP, Pearson D, Okawa J, Feng R, Concha J, Patel B, Hejazi E, Cornwall C, Constantine S, White B. Safety and Efficacy of Lenabasum in Refractory Skin-Predominant Dermatomyositis Subjects Treated on an Open-Label Extension of Trial JBT101-DM-001 [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/safety-and-efficacy-of-lenabasum-in-refractory-skin-predominant-dermatomyositis-subjects-treated-on-an-open-label-extension-of-trial-jbt101-dm-001/. Accessed January 31, 2023.
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